Kornimate/medical-research-clean huggingface dataset:
the psychology of chinese breast cancer patients

Conditions: Breast Cancer

Summary: earlier diagnosis of breast cancer in women and the use of systemic adjuvant therapy have increased the likelihood of long term, disease free survival.women who remain free of breast cancer seem to have levels of functioning and quality of life that are comparable to those of the general female population.it will be assessed the psychology status of women with breast cancer using a clinical interview,

it conducts a questionnaire survey of 300 patients. the questionnaires used are: psychological pain thermometer dt, hospital anxiety and depression scale hads, quality of life scale for breast cancer patients fact-b, social support rating scale ssrs. caregivers should fill in the following scales: psychological pain thermometer dt, hospital anxiety and depression scale hads, caregiver burden assessment scale zbi. inclusion criteria: 1,female patients with early breast cancer after surgery; 2,no previous mental and psychological abnormalities; 3,postoperative and prepare to accept adjuvant chemotherapy ; 4,patient's know her/his illness . to explore: 1. psychological status and dynamic changes of patients and caregivers during adjuvant chemotherapy after breast cancer surgery in china. 2. the influence of psychological status of chinese breast cancer patients on adverse reactions during adjuvant chemotherapy. 3. gene susceptibility to psychological abnormalities during adjuvant chemotherapy for breast cancer in china.

Eligibility criteria:
inclusion criteria: age：18\~75 years; early stage breast cancer confirmed by histology examination; patients had undergone surgery for breast cancer; no distant metastasis; planned to receive recommended postoperative adjuvant chemotherapy; voluntarily provided written informed consent. exclusion criteria: patients already receiving neoadjuvant chemotherapy before surgery; patients had metastatic disease at diagnosis; patients had difficulty understanding the questionnaire or communicating in chinese; patients had significant psychiatric or other comorbid disease prohibiting participation; any other researcher believes that it is not appropriate to participate in this test.
application of 3d printing guide plate in dorsal root ganglion intervention treatments

Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis

Summary: this study applies 3d-printed customized guide plate in assisting the accurate puncture in transforaminal epidural steroid injection (tfesi) combined with pulsed radiofrequency (prf) treatment. this technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.

lumbar disc herniation (ldh) is a common degenerative spine disease and it can cause low back pain and lumbosacral radicular pain (lsrp). transforaminal epidural steroid injection (tfesi) is one of the most common minimally invasive interventions for the treatment of ldh. tfesi combined with dorsal root ganglion pulsed radiofrequency (prf) is an effective procedure for treating lsrp. needle puncture is the key technology in this procedure. in the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of c-arm fluoroscopy or ct. if the position of the needles is not satisfactory, repeated procedure will be performed. this would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. this problem is well solved by applying the 3d printing guide plate. the application procedure for the the 3d printing guide plate: the model of the spine is established according to the patient's ct scan data to prepare the customized guide plate, then sterilize them for future use. the final position of needle is confirmed by c-arm fluoroscopy or ct.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, 2. chronic lumbosacral radicular pain lasting ≥12 weeks, 3. dominant leg pain with less intense back pain, 4. the previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications, 5. pain intensity≥4 out of 10 on the numerical rating scale (nrs), 6. segmental pain of a radicular nature originating from the lumbar segments and with a shooting or lancinating quality corresponding to a dermatome suggestive of the involved nerve root, 7. availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features. exclusion criteria: 1. patient refusal to participate in the study, 2. pregnant or nursing 3. progressive motor weakness in the affected leg, 4. allergies to local anesthetics, contrast dyes or steroids 5. significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging 6. presence of cancer accounting for back pain 7. patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment 8. steroid injection within the previous 12 weeks, 9. systemic infection, 10. injection site infection, 11. unstable medical or psychiatric condition

Keywords: transforaminal epidural steroid injection dorsal root ganglion pulsed radiofrequency 3d printing guide plate lumbosacral radicular pain
effect of exercise on the disease activity of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weightlifting.

the goal of this study was to evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis. it was hypothesized that persons would have less inflammation associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weighlifting. immune parameters were measured to determine potential mechanisms responsible for changes in inflammation with exercise.

Eligibility criteria:
inclusion criteria: * a diagnosis of ra according to the acr 1989 criteria at least 6 months prior to enrollment in the study, but not longer than 12 years * age 19 to 65 years old * stable regimen of medication for 2 months with less than 10 mg/day of oral corticosteroids * currently exercise \< 2x/week for less than 30 minutes at less than 60% of his/her age predicted maximum heart rate * subjects must pass the physical activity readiness scale questionnaire (par-q) exclusion criteria: * other serious health problems * intra-articular injection within 6 weeks * total joint replacement of the large joints * use of beta-blockers * inability to complete the submaximal exercise test

Keywords: exercise disease activity inflammation resistance training rehabilitation
intraoperative ultrasound in patients undergoing transsphenoidal surgery for pituitary adenoma

Conditions: Pituitary Adenoma

Summary: pituitary adenoma can be difficult to cure with approximately a third of patients in contemporary series' undergoing incomplete resection. over the last decade or so a handful of groups have described the use intraoperative ultrasound to improve resection. although limited, these proof-of-concept studies suggest intraoperative ultrasound is a safe and effective technological adjunct to transsphenoidal surgery for pituitary adenoma. in this prospective development study 30 adult patients will undergo transsphenoidal surgery for pituitary adenoma with prototype intraoperative ultrasound devices. the primary outcomes will be technical feasibility and device safety. the secondary outcomes will be complete versus incomplete radiological resection, endocrinological remission, the occurrence of postoperative complications, operating time, and length of stay.


Eligibility criteria:
inclusion criteria: * adult patients * undergoing transsphenoidal surgery * diagnosis of pituitary adenoma on pre-operative mri * able to provide consent exclusion criteria: * patients less than 18 years of age * patients undergoing transcranial surgery * diagnosis other than that of pituitary adenoma on pre-operative mri e.g., meningioma * unable to provide consent e.g., mental illness or later withdrawing consent.
a study to compare pharmacokinetics (pk) and pharmacodynamics (pd) of sar341402 to insulin aspart in subjects with type 1 diabetes mellitus

Conditions: Type 1 Diabetes

Summary: primary objective: to compare exposure and activity of sar341402 to novorapid® and novolog®. secondary objective: to assess the safety and tolerability of sar341402.

the total study duration for a screened subject will be about 3 - 8 weeks (excluding screening of 2 to 28 days), treatment period of 2 days for each 3 periods (1 overnight stay), a washout period of 5-18 days (preferentially 7 days between consecutive dosing), and an end-of-study visit of 1 day between days 5 and 14 after the last administration of the investigational product.

Eligibility criteria:
inclusion criteria : * male or female subjects with diabetes mellitus type 1 for more than one year. * total insulin dose of \< 1.2 u/kg/day. * fasting negative serum c-peptide (\< 0.3 nmol/l). * glycohemoglobin (hba1c) ≤ 9%. * stable insulin regimen for at least 2 months prior to study. * normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ecg) and safety lab. exclusion criteria: * any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. * more than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months. * frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month. * symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmhg within 3 minutes when changing from supine to standing position. * presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. * likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol. * any medication (including st john's wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of insulins, thyroid hormones, lipid-lowering and antihypertensive drugs and if female with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days. * positive result on any of the following tests: hepatitis b surface (hbs ag) antigen, anti-hepatitis c virus (anti-hcv) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-hiv1 and anti hiv2 ab. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
nourishing the community through culinary medicine

Conditions: Diabetes

Summary: the purpose of this study is to adapt existing nourish program curriculum for synchronous virtual delivery,to implement adapted virtual culinary medicine (cm)curriculum among target population, to assess if program participation improves participant dietary behaviors, nutrition knowledge, and cooking skills and behaviors above standard of care, to assess if program participation improves patient levels of hba1c, body mass index, blood pressure, hdl, ldl and triglycerides above standard of care and to determine the feasibility and reproducibility of virtual synchronous cm classes in patients with diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes and glycosylated hemoglobin (hba1c) \>7.0 * receiving care at sanitas medical center clinics in august 2021 - august 2023 * english speaking or spanish speaking. exclusion criteria: * patients without the technological support needed to participate in the program (e.g., reliable internet and device - cell phone, tablet or laptop); * patients with terminal or late-stage conditions (e.g., advanced stage chronic kidney disease); * patients with uncontrolled mental disorder that interferes with participation in active programming; * patients with physical impairment that interferes with participation in active programming
phase 1 study of bht-3021 in subjects with type 1 diabetes mellitus

Conditions: Diabetes; Hypoglycemia

Summary: the purpose of this study is to determine the safety of bht-3021 injections given weekly for 12 weeks and to evaluate the effect of bht-3021 on antibody and immune (t cell) responses to autoantigens (e.g. insulin). changes in pancreatic beta cell function, insulin requirements and blood glucose levels will also be evaluated.

type 1 diabetes results from an attack by the body's own immune system on the insulin producing cells in the pancreas. around 80% of diagnosed patients have detectable antibodies to islet cell self-proteins including, insulin ia-2 and glutamic acid decarboxylase. the drug, bht-3021 is being studied because an agent that stops autoimmune damage could offer patients benefit. study description: a randomized, blinded, placebo controlled, safety and pharmacodynamic study of bht-3021 with open label cross-over in subjects with type i diabetes mellitus that will enroll up to 72 subjects in this trial. subjects will be randomized to bht-3021 or bht-placebo in a 2:1 ratio. the duration of the study is approximately 25 to 37 months depending on treatment assignment: 4 week screening period; 12 month blinded treatment and evaluation period; 12 month cross-over treatment and evaluation period (bht-placebo subjects only); 12 month long term follow-up period.

Eligibility criteria:
inclusion criteria * diagnosis of type 1a diabetes mellitus based on ada criteria * ≤5 years since t1d was diagnosed * ≥ 18 years of age * ≤ 40 years of age at the time of diagnosis of type 1a diabetes * presence of antibodies to at least one of the following antigens: insulin, gad-65, or ia-2 * detectable fasting c-peptide level * c-peptide increase during screening mixed meal tolerance test with a minimal stimulated value of ≥ 0.2 pmol/ml * presence of antibodies to at least one of the following antigens: insulin, gad-65, or ia-2. if insulin antibody positive only, determination must be within 2 weeks of insulin initiation exclusion criteria: * bmi \> 30 kg/m2 * unstable blood sugar control defined as one or more episodes of severe hypoglycemia (defined as hypoglycemia that required the assistance of another person) within the last 30 days * current use of inhalable insulin * previous immunotherapy for t1d * administration of an experimental agent for t1d at any time or use of an experimental device for t1d within 30 days prior to screening, unless approved by the medical monitor * history of any organ transplant, including islet cell transplant

Keywords: diabetic diabetes type 1 diabetes type 1 diabetes mellitus autoimmune disease
evaluation of molecular forms of psa and human kallikrein 2 in a cohort of patients with locally resected prostate cancer but biochemical recurrence

Conditions: Prostate Cancer

Summary: the purpose of this study is to investigate if a new blood test looking at psa and a group of psa related proteins in a patient's blood can indicate which men after surgery with a rising psa could benefit from treatment, and/or indicate which men are at higher risk for recurrence before initial treatment is given.


Eligibility criteria:
inclusion criteria: * all patients treated with radical prostatectomy that develop a rising serum psa ≥ 0.05ng/ml and have not received any kind of additional therapy. * patients who have had additional therapy post radical prostatectomy are eligible for this study if ≥1 year has passed since treatment and the patient develops a rising serum psa ≥0.05ng/ml. exclusion criteria: * previous additional therapy for prostate cancer, less than 1 year ago * no evidence of rising psa * patients unwilling to undergo venesection

Keywords: psa human kallikrein 2 locally resected prostate cancer biochemical recurrence 14-041
oral quality of life

Conditions: Odontalgia

Summary: the restorative and surgical odontological department at the nantes university hospital frequently hosts patients with a severely degraded oral condition who has never benefited from a removable prosthetic rehabilitation. the chosen treatment plan consists most of the time in extracting all the residual teeth at one or both arches with the immediate insertion of a complete removable prosthesis performed prior to the extractions. this prosthesis is adapted by regular relining during the osteomucosal healing and is replaced by a usage removable prosthesis on average 6 months after the extractions. the transition from dentate state (even dilapidated) to toothless state can be a source of discomfort and impairment and lead to a decrease of life's quality for patients. the purpose of this study is to evaluate oral health of the patients at the different stages of prosthetic rehabilitation by using gohai (geriatric oral health assessment index).

patients are selected at the beginning of their prosthetic rehabilitation and selected patients give their consent for the participation at the clinical trial. the filling of the gohai questionnaire is performed in 3 steps:1- before treatment, 2- after teeth extractions and the delivering of immediate complete denture or without immediate prosthetic rehabilitation and 3-during inspection visits after the delivery of the definitive denture.

Eligibility criteria:
inclusion criteria: * an adult man or a woman, speaking and understanding french, benefiting from social security cover. * patient presenting one or more teeth to be extracted, these extractions resulting in a complete uni or bimaxillary edentulism rehabilitated or not by an immediate complete removable prosthesis. exclusion criteria: * patients under the age of majority, patients under protection, protected persons, patients refusing to participate in the study, patients whose follow-up can't be performed, patients who don't speak french and patients who don't benefit from social coverage. * patients rehabilitated by immediate partial removable prosthesis (persistence of teeth on the rehabilitated arch).

Keywords: edentulism complete removable prosthesis quality of life
neonate cerebral activity in immediate post partum

Conditions: Anoxia-Ischemia, Brain; Neonatal Encephalopathy

Summary: neonatal anoxia-ischemia causes significant neurodevelopmental disorders. in this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation of the neonate to ectopic life just after birth. birth is an at risk situation of neonatal anoxic ischemia and the lack of objective criteria for cerebral tissue oxygenation has consequences on neuronal activity. ph cord analysis is inadequate and only indirectly reflects the state of cerebral oxygenation. both neuronal and vascular systems are part of the same functional entity and the analysis of their interactions is likely to reveal some early malfunctions of these networks. in this study, the investigators want to develop a multi-scale, multimodal approach that allows simultaneous interrogation of both neuronal and vascular compartments during the 15 minutes after delivery. the investigators will record, with the aid of a single sensor placed on the scalp of the child, the electroencephalogram and the cerebral tissue oxygenation. the investigators will measure interactions by means of correlation analysis between both signals.


Eligibility criteria:
inclusion criteria: * full term neonates between 36 and 41 weeks gestational age exclusion criteria: * premature neonates * neonates of twin pregnancy * suspicion of congenital malformation seen in antenatal ultrasound * any pathology requiring pediatric care from birth * newborns whose mothers had a chronic viral infection such as aids, hepatitis b or c, or who had a multidrug-resistant bacteria

Keywords: anoxia-ischemia, brain postpartum electroencephalography cerebral oxymetry near infrared spectroscopy eeg nirs neonate
tracheal suctioning with or without expiratory pause maneuver in children

Conditions: Mechanical Ventilation Complication; Pediatric Respiratory Diseases

Summary: the purpose of this study is to evaluate the efficacy of tracheal suctioning associate with expiratory pause maneuver in children on invasive mechanical ventilation.

after being informed about the study and potential risks, all parents or guardians giving written informed consent will be evaluate for study entry. children in invasive mechanical ventilation who meet eligibility criteria will be submitted of two techniques of tracheal suctioning (with and without expiratory pause maneuver), randomized in a crossover trial in a 1:1 ratio, for determine the first technique to be applied. clinical data will be collected (sex, age, presence of previous disease, diagnosis of hospitalization), as well as the ventilatory parameters (ventilation mode, peak inspiratory pressure, positive end-expiratory pressure, tidal volume, respiratory frequency, fraction of inspired oxygen). the protocol consists of an initial conventional tracheal suctioning with a negative pressure of 40mmhg for all the participants. after two (2) hours the first technique will be applied and an interval of another two hours for the application of the second technique. respiratory mechanics and hemodynamic parameters will be evaluate before and after 30 minutes of each tracheal suctioning techniques. in case of clinical alterations that may aggravate the patients condition during the protocol (oxygen saturation \ 190bpm and/or decrease 20% of mean arterial blood pressure), the technique will be interrupted immediately and the patient will be evaluated.

Eligibility criteria:
inclusion criteria: * children at invasive mechanical ventilation for more than 24 hours; * under the effect of neuromuscular blocker (level of sedation assessed using the comfort b scale with a score \<10 and without a cough reflex); * endotracheal suctioning in a period \> 2h before the application of the technique. exclusion criteria: * patients with undrained pneumothorax or hemothorax, or presence of subcutaneous emphysema; * hemodynamic instability (hypotension refractory to treatment) * need of frequent endotracheal suctioning

Keywords: pediatric critical care respiratory mechanics tracheal suctioning mechanical ventilation